Sovaldi's criteria for re-examination are relaxed

Sovaldi & Harvoni apply for mediation due to not being able to fill 3,000 cases before the end of re-examination

The Central Pharmaceutical Affairs Review Committee, reduced to 1840 cases and 798 cases, respectively, Reduction of prescriptions and reflection of inevitable circumstances such as COVID-19

It can be cured plunged 2% last year from 62% of the market share in 2017

Re-examination criteria of Sovaldi (Sofosbuvir) and Harvoni (Sofosbuvir-Ledipasvir) by Gilead Science Korea are relaxed.

 

This is because the emergence of new drugs and the continuation of COVID-19 epidemic make it difficult to conduct sufficient usability surveys.

 

Since the recently released hepatitis C treatment can be cured, the number of patients is decreasing.

 

According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee held last month decided to reduce the number of cases in the post-marketing investigation plan of Sovaldi and Harvoni.

 

Sovaldi and Harvoni received domestic permits in the second half of 2015, and re-examination ends in September and October of this year respectively.

 

New drugs usually need to be investigated for a certain period of time in order to verify side effects after marketing.

 

In the case of Sovaldi and Harvoni, conditions were imposed to conduct investigations of 3,000 patients each for 6 years.

 

If this is violated, the marketing permission is finally canceled along with administrative disposition.

 

The Central Pharmaceutical Affairs Review Committee concluded that it is reasonable to adjust the number of Sovaldi and Harvoni cases from 3000 to 1840 and 798.

 

The reason is that although the number of patients has rapidly decreased due to the emergence of new drugs and the environment of COVID-19.

 

In the minutes of the Central Pharmaceutical Affairs Review Committee meeting, a member said, "This drug is difficult to register for new subjects due to COVID-19 situation and the decrease in prescription itself as the use of other drugs increases and the number of subjects to be treated decreases.” He said, "The number of investigation cases is insufficient to confirm the incidence of abnormal cases according to the results of the investigation after overseas marketing, but it is judged that the plan revision is inevitable." He added, "We recommend that they submit a PSUR to maintain drug surveillance after the end of the post-marketing investigation."

Most of the committee members concluded that it is reasonable to adjust the number of cases considering the environment of this drug.

 

In fact, Sovaldi's market share in 2017 was 62% due to the decline in patients, and last year it was only 2%.

 

Last year's outpatient prescription (UBIST) was only ₩900 million.

 

Harvoni's outpatient prescription sales last year was ₩8.6 billion, down half from the initial launch.

 

Sales of Mavyret are also declining.

 

Mavyret's outpatient prescriptions last year were ₩32.6 billion, down 26.6% from the previous year.

 

The Central Pharmaceutical Affairs Review Committee explained that although the use of Sovaldi and Harvoni has declined, it is still essential for the treatment of Hepatocirrhosis genotypes 2 and 3.